FDA.reportPublic FDA data

TrenGuard™

Primary DI
00811836030150
Brand
TrenGuard™
Company
Dan Allen Surgical LLC
Model
55251
Catalog number
56100
Device description
TrenGuard 450 HYBRID Reusable Lateral Stabilizing Pillow - Reusable Lateral Stabilizing Pillow for use with HYBRID system.
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811836030150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811836030150008118360301508118360301500811836030150

GMDN Terms#

Term, Definition table
TermDefinition
Torso intraoperative positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040876183
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811836030273ShroudGuard™373502025-07-09
00811836030266ShroudGuard™OZ 8800200382025-03-11
00811836030891TrenGuard™569492024-11-11
00811836030204TrenGuard™56400564002022-08-18
00811836030006TrenGuard™56100561002021-05-17
00811836030815TrenGuard™569292021-05-17
00811836030075ShroudGuard™373032024-11-11
00811836030440TrenGuard™546122024-11-11
00811836030600ShroudGuard™371102024-11-11
00811836030846TrenGuard™548122024-11-11
00811836030259ShroudGuard™373242024-10-24
00811836030754ShroudGuard™373142024-06-25
00811836030761ShroudGuard™373122024-06-25
00811836030778ShroudGuard™373102024-06-25
00811836030860TrenGuard™569102023-01-31
10811836030089TrenGuard™553012021-05-17
10811836030102TrenGuard™552012021-05-17
10811836030140TrenGuard™554012021-05-17
10811836030171TrenGuard™561012021-05-17
10811836030195TrenGuard™562012021-05-17

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Primary DI, Brand, Company table
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00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
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07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
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